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China FDA – The Regulation of Medical Devices Recall Administration

On September 30, 2016, the Legislative Affairs Office of the State Council has released a notice on CFDA soliciting public opinions on The Regulation of Medical Devices Recall Administration (draft for soliciting opinions), aims to strengthen the management of medical devices recall. The deadline of submission time is October 30, 2016. Office for CFDA has issued the first draft of The Regulation of Medical Devices Recall Administration.

In general, most of these regulations solicit opinions twice. Therefore, newly-founded Regulation of Medical Devices Recall Administration is coming out. You can refer to the Legislative Affairs Office of the State Council website to view relevant content and give your advice.

Compared to the first draft, the main difference is Chapter Legal Responsibilities. This time Article 29 in the first draft was deleted: In violation of this regulation such as, the manufacturers not actively recalling the devices when defects are detected, mandatory measures will come into force, with a penalty of three times the price of supposed to be recalled devices; the certificate of medical device registration record should be revoked by the original authorization department if caused serious consequences, until the revocation of Medical Device Manufacturing License.

 

 

The Regulation of Medical Devices Recall Administration (draft for soliciting opinions)

 

 

Chapter 1

General Guideline

Article 1

For better supervision and administration of medical devices, detection and control of the defective products of medical devices, to eliminate potential safety hazard of medical devices, ensure the medical device is safe and effective, and to guarantee people’s health and safety, according to Regulation on the Supervision and Administration of Medical Devices, this legislation is drafted.

 

Article 2

This legislation applies to recall, supervision and administration of medical devices sold within People’s Republic of China.

 

Article 3

The definition of medical devices recall means that manufacturers of medical devices (including the appointed agencies in China of the imported medical devices manufactured overseas, similarly hereinafter) take actions to eliminate the defects of the already marketed devices, such as warning, checking, fixing, re-labeling, amending, completing user’s manual, software updating, replacing, recalling, and destroying.

 

Article 4

The defective products according to this regulation include:

  1. The medical devices that may be of unreasonable safety or health hazards to people when operated under normal conditions;
  2. The medical devices does not meet the mandatory standards and registered or filing technical requirements;
  3.  The medical devices that are not in accordance with the relevant regulations of production and circulation quality management;
  4. Other products need to be recalled.

 

Article 5

Manufacturers of medical devices play a major role in managing and eliminating defective products, therefore they must take the initiative to recall defective products.

 

Article 6

Under this regulation, the medical devices manufacturers are to establish their recalling system, to collect the related information regarding the safety of medical devices, and to investigate, estimate their possible products, in order to recall these defective medical devices in a timely manner.

The appointed agencies in China of the imported medical devices manufactured over-seas should report information of recall implemented overseas merely to CFDA; on condition that the recall is implemented within PRC, the appointed agencies should carry out according to this regulation.

Companies that run business with or make use of medical devices should actively assist manufacturers to investigate and evaluate the defective products, carry out recalling obligations, promptly transmit recalling information and feedback, control and recall defective products.

 

Article 7

On condition that companies that run business with or make use of medical devices discover the medical devices they possess are defective, the usage and marketing of these products should stop immediately, while they should inform the manufacturing and supplying parties of these certain products, and report to the local Food and Drug Administration and Supervision Department; the organizations making use of these devices are to report to the Health Administration of the province , Autonomous Region or Municipality under the Central Government as well. After receiving the reports from these companies, the Administration Department should notify the Health Administration of the province, Autonomous Region or Municipality under Central Government of the manufacturing company.

 

Article 8

The Food and Drug Administration of the province, Autonomous Region or Municipality under Central Government of the manufacturing company are in charge of recalling supervision and management, and the other provinces and regions equivalent to it should provide with assistance, cooperate this region with related recalling work. The CFDA is in charge of the management of recalling of medical devices national-wide.

 

Article 9

CFDA and the FDA of the province, Autonomous Region or Municipality directly under the Central Government should set up a public system for the recalling of medical devices, effective measures should be taken leading to publication of the information and reclamation of the defective devices to the society, report relevant information to health administrations of the equivalent level.

 

 

Chapter 2

Investigation and Evaluation of Defective Medical Devices

 

Article 10

The manufacturers should establish the quality management controlling system and the supervision system in times of defective incidents, to report, collect the information with regards to the quality complaints and defective incidents of medical devices. And investigate and evaluate the possible defects of medical devices.

Companies that run business with or make use of medical devices should cooperate with the manufacturers to investigate and provide relevant documents of the defective products.

 

Article 11

The manufacturers should promptly collect and report to the CFDA Department regarding defective events, and the CFDA Department can estimate and investigate the possible defective events, and the companies that run business with or make use of the medical devices should provide assistance.

 

Article 12

The evaluation of defective devices mainly includes:

  1. Whether a malfunction or harm has occurred during usage;
  2. Whether the medical device will do harm when used under current conditions, and whether the reasons of such harms can be explained by the scientific papers, researches, or relevant exams;
  3. The features of the regions and its people involved where the harms occurred;
  4. The degree of harm done to people’s health;
  5. The occurring ratio of such harm;
  6. The short and long term results of such harm;
  7. Other possible factors that could bring harm to people.

 

Article 13

According to the seriousness of the defective devices, they are categorized into:

  1. Level one recall: serious harm to public health may or have already occurred using this medical device;
  2. Level two recall: temporary or reversible harm to health may or have already occurred using this medical device;
  3. Level three recall: the possibility of harmful events occurring is minimal using this certain medical device, but still it needs to be recalled.

The manufacturers need to organize and carry out the recall in an objective way, emphasizing scientific methods of investigation, according to the categories of the seriousness of defects, and the sales and usage of the devices.

Chapter 3

Active Recall

 

Article 14

According to Article 10, 12, after the investigation and evaluation of the medical devices, confirm that these are defective devices; decisions involving product recall should be made immediately.

 

Article 15

For the decisions made to recall the medical devices, notices have to be sent to the related companies or individuals that run business with or make use of the medical devices. Level One is within 1 day, Level Two is within 3 days, and Level Three is within 7 days.

The recalling notice at least contain the following contents:

  1. The names, batch information of recalled medical devices;
  2. The reason for the recall;
  3. The requirement of the recall: such as to suspend the sales and usage of these products, forward the recall notice to the related operating and using companies;
  4. The process KPIs of these recalled products.

 

Article 16

Decisions upon the recall of the medical devices by the manufacturers should formally notified to the CFDA Department of the province, autonomous region or municipality directly under the Central Government, and a Report of Device recalled incidents should be filled in 5 days. (See Appendix 1), and a report and proposal of investigation and evaluation should be handed in to the CFDA of the province, Autonomous Region or Municipality directly under the Central Government for record.

FDA of the province, Autonomous Region or Municipality directly under the Central Government should promptly report to the CFDA for Level One events.

 

Article 17

The investigation and evaluation report should include the following information:

  1. Detailed information of the recalled medical devices, including basic information such as names and batch;
  2. The reason for the recall;
  3. The results of the investigation and evaluation;
  4. Recalling classification.

The recall plan should include following content:

  1. The sales of medical devices and the number of devices to be recalled;
  2. The detailed information of recall, including implementing organization, extent and time limit;
  3. The approach and range of publishing recall information;
  4. The expected results of recall;
  5. Measures after recalling

 

Article 18

CFDA of the province, Autonomous Region or Municipality directly under the Central Government can evaluate their proposals of recall submitted by medical devices manufacturers. If the proposal is considered ineffective of the elimination of the defects, manufacturers should be ordered to upgrade the recall level, expand the recalling range, shorten recalling time or alter the measures to be taken for more effective measures.

 

Article 19

For decisions made by the manufacturers to alter the recalling proposals that are already reported, a back-up record should be proposed promptly to the China Food and Drug Administration.

 

Article 20

During the recall procedure of the medical devices manufacturers, a Report of the Enforcement of Recall Schedule (See Appendix 2) should be sent regularly to the FDA. It is to report the actual enforcement of the proposal.

 

Article 21

Detailed records should be kept for the handling of recalled medical devices, and to report to the FDA of the province, Autonomous Region or Municipality directly under the Central Government where the manufacturers are located. As for the defects that can be eliminated by means of warning, checking, fixing, relabeling, or amending the devices’ user’s guide, update its software, replacement or destruction, such measures can be taken where the manufacturer is located. If in need of destruction, such measures should be taken under the supervision of the local FDA.

 

Article 22

After completing the recalling of medical devices, result evaluation should be carried out, and a summary report should be submitted to the FDA of the province, Autonomous Region or Municipality directly under the Central Government.

 

Article 23

Investigation by the CFDA Department shall start within 10 days after receiving the summary report to evaluate the effects of the recall. If the elimination of defects is still considered ineffective, manufacturers should be required to reprocess the recalling procedure.

 

Chapter 4

Mandatory Recall

Article 24

After the investigation and evaluation of the CFDA Department, if the product recall was not initiated by the manufacturers and the defective products of medical devices still exist in the market, mandatory recall is activated.

If necessary, CFDA Department requires immediate suspension of productions, sales and usage of the manufacturing, dealing or operating companies, and inform consumers of suspending the usage of defective products immediately.

 

Article 25

A notice should be sent to manufacturers of medical devices when the CFDA Department makes the decision of mandatory recall. The notice should include the following information:

  1. Detailed information of the recalled medical devices, including basic information such as names and batch;
  2. The reason for the recall;
  3. The results of the investigation and evaluation;
  4. The requirements of the recall, including its extent and time limit.

 

Article 26

Upon receiving the notice of the recall, the manufacturers of medical devices should formulate, submit and help carry out the recalling proposal, as well as inform the companies or individuals that run business or make use of the medical devices according to Article 15 and 16.

 

Article 27

The manufacturers should report the product recall related matters to the FDA Department according to Article 19, 20, 21, 22, and handle the follow-up pressures.

The FDA Department should investigate the report according to Article 23, evaluate the result of the recall, and report to the Health Administration Department of parallel level if necessary. After the investigation and evaluation, if there are still defects that are considered not effectively eliminated, a new product recall should be activated accordingly by the CFDA Department.

 

Chapter 5

Legal Responsibilities

 

Article 28

If defects of marketed devices are confirmed by the FDA Department due to violation of law, regulations or rules, administrative punishment should take place according to the law. For the companies have already taken recalling measures to actively eliminate or alleviate the harms occurred, a lesser or reduced punishment should be taken into action according to the Law of Administrative Penalties, if the illegal activities are minor and are corrected timely, with no harms done, they should be scot-free.

No exemptions of other legal responsibilities should occur when the manufacturers are to recall their medical devices.

 

Article 29

In violation of Article 24, the manufacturers refuse to recall the devices; punishment according to Article 66 of Administration of medical devices will be taken.

 

Article 30

The manufacturers should receive warning, mandatory correction order in case of the occurrence of circumstances listed below, and be punished with a penalty of no more than 30,000 RMB.

  1. In violation of Article 15, a recalling notice of the medical devices is not forwarded to the dealing and operating companies or individuals;
  2. In violation of Article 18, section 2 of Article 23, section 2 of Article 27, no correction or recalling measures are taken according to the regulations of FDA Department;
  3. In violation of Article 21, no detailed records of the handling of the recalled devices are kept, or not reporting to the Food and Drug Administration Department.

 

Article 31

The manufacturers should receive warning, mandatory correction order in case of the occurrence of circumstances below, the manufacturers not corrected after the time limitation, a penalty of no more than 30,000 RMB will be charged.

  1. Not establishing the recall system according to this regulation;
  2. Refusing to assist with investigation of the Food and Drug Administration Department;
  3. Not submitting the Report of Device Recalled Incidents, investigation evaluation report, recalling schedule and enforcement and summary of the recall of medical devices;
  4. Modification of the recall schedule, but not yet reported to Food and Drug Administration Department.

 

Article 32

Companies dealing and operating the medical devices in violation of Article 7, section 1, will be ordered to cease selling or using the defective devices, and will be fined with a penalty over 1,000 and no more than 30,000 RMB; if caused serious consequences, their Medical Devices Business Certificate will be suspended by the authorization department.

 

Article 33

For companies dealing and operating the medical devices that refuse to cooperate with defection of the defects, or assist the manufacturing company with recall of the devices, a warning of immediate correction will be given; if not, a fine of no more than 30,000 RMB will be charged.

 

Article 34

Employees at the FDA Department in violation of their duties or abuse their authorities, will take equivalent punishment according to relevant laws and regulations.

Chapter 6

Supplementary Articles

 

Article 35

On condition that the medical device to be recalled has already been panted into the patient, the manufacturing company should negotiate with medical institution and patient according to the various reasons, and put forward a solution and contingency plan.

 

Article 36

The patients can claim for damage caused by the defective medical devices from the manufacturing, dealing or operating companies. The dealing and operating companies have the right to pursue compensation from the manufacturing company after granting their compensation to the patients.

 

Article 37

This regulation takes effect from  (TBD date

 

WHEW!!

 

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